N/A
Completed N=9
Follow-up Yttrium-90 Internal Pair Production PET/CT vs Brehmsstrahlung Imaging in Patients With Primary/Metastatic Liver Tumors
Source: ClinicalTrials.gov NCT02202317 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: Number of Subjects Whose Y-90 Based PET/CT (Positron Emission Tomography/Computed Tomography)Scans Detected Extrahepatic Non-target Embolization. — 0 Participants
Summary
This is a prospective non-blinded case series involving the acquisition of a pair production PET/CT as soon as possible after an already performed Y-90 Sirspheres treatment of hepatic malignancy. It will be performed in addition to the standard Brehmsstrahlung SPECT scan. The sequence of the two scans in each case (PET/CT vs SPECT) will be determined by availability of the scanners at the time. However, it is intended that both be acquired on the day of the Y-90 treatment.
The length of subject participation will be one year.
The measures used will be mostly qualitative in nature, and will include:
* Correlation with expected vs. achieved tumor coverage by the treatment
* Correlation between treatment distribution depicted by Brehmsstrahlung scans vs. the Internal Pair Production PET/CT scans, to.
* Detection of non-target embolization, where applicable, and qualitative comparison between the two modalities as to the conspicuity of the abnormality
Qualitative methods will be used by the analysis of the obtained PET/CT images and comparing them to the Brehmsstrahlung SPECT images as previously described.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Whose Y-90 Based PET/CT (Positron Emission Tomography/Computed Tomography)Scans Detected Extrahepatic Non-target Embolization. |
— | — |
| SECONDARY Comparison Between Treatment Distribution Depicted by Tc99mMAA (Technetium-99m Macroaggregated Albumin) Brehmsstrahlung Scans vs. the Internal Pair Production PET/CT Scans. |
8 | — |
| SECONDARY Comparison of Y-90 PET/CT to Y90 SPECT |
8 | — |
Eligibility Criteria
Inclusion Criteria
- Recipient of Selective Internal Radiation Treatment within 5 days.
- Anticipated ability to remain still for up to 40 minutes
Exclusion Criteria
- Anticipated Inability to lie still for up to 40 minutes
- Severe claustrophobia
- Significant cardiovascular instability, or instability of other medical/surgical conditions, such that it would be deemed unsafe or technically not feasible to obtain a PET/CT, as determined by the any member of the investigative team
- Failed deployment of the planned Y-90 treatment for any reason
- Duration of time longer than 5 days since administration of the Y-90 treatment
- Age <18
- Known pregnancy
Data sourced from ClinicalTrials.gov (NCT02202317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.